PMA P900056S224

Device: Rotablator™; ROTAPRO™ Rotational Atherectomy Systems
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S224
Product code: MCX
Decision date: 2026-04-09
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: transfer of manufacturing activities of the ROTAWIRE Drive guidewire and wireClip Torquer guidewire manipulation devices from the BSC Heredia, Costa Rica facility to the BSC Coyol, Costa Rica facility

Current openFDA PMA Record#

Device: Rotablator™; ROTAPRO™ Rotational Atherectomy Systems
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S224
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2026-04-09
Decision code: OK30
Date received: 2026-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transfer of manufacturing activities of the ROTAWIRE Drive guidewire and wireClip Torquer guidewire manipulation devices from the BSC Heredia, Costa Rica facility to the BSC Coyol, Costa Rica facility